MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM9620N40
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed dried body fluid found under the ring 1 distal seal and along the distal edge of the ring 1 electrode, dried body fluid also found on the handle, main body and distal end and dried saline found on the distal end and inside the irrigation holes.Electrical tests were done and continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box and all electrodes and thermocouple resistances measured in spec and were typical.Functional inspection was done and the steering knob and the tension control knob functioned properly on both lock and unlock positions and no abnormal resistance was felt when actuating the steering mechanism.Connected device to a maestro 4000 to measure tip temperature.During 5 minutes at room temperature (21.8c), the maestro displayed 22c and after soaking 5 minutes in a tank of 37.0c saline, the maestro displayed 37c through temperature testing.Rf ablation test was done and verified by using a maestro generator 4000, a metriq pump, and a tank of 37c saline solution.The device was found within specifications.Secondary findings revealed body fluid ingress under the distal ring 1 seal.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 19-july-2018.It was reported that the catheter had high sensor temperature display.A 7.5/110/2.5/4.5 n4 intellatip mifi open-irrigated ablation catheter was selected for an ablation procedure.During preparation, no visual issue was observed on the catheter.However, during procedure, it was noted that the catheter had high sensor temperature display when inserted into the patient.The procedure was completed with a different device.No patient complications and no injuries were reported.However, returned device analysis revealed a body fluid ingress was found under the ring 1 distal seal and along the distal edge of the ring 1 electrode.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7718294
• Report Number: 2134265-2018-07126
• Device Sequence Number: 1065243
• Product Code: OAD
• UDI-Device Identifier: 08714729848707
• UDI-Public: 08714729848707
• Combination Product (Y/N): N
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: M004PM9620N40
• Device Catalogue Number: PM9620N4
• Device Lot Number: 20775597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1